edx110 - efficacy and safety in the management of hard-to-heal wounds

Conditions: Wound Healing; Diabetic Foot; Foot Ulcer, Diabetic; Venous Ulcer

Summary: post-market study to determine the efficacy of edx110 dressing system in hard-to-heal wounds.

prospective, single-center, non-blinded, non-randomized, post-market study to determine the efficacy of edx110 dressing system in diabetic foot ulcers (dfus) and venous leg ulcers (vlus).

Eligibility criteria:
inclusion criteria: * subjects ≥18 years old and willing to participate in all procedures and follow-up evaluations necessary to complete the study * an index ulcer meeting the following characteristics: * diabetic foot ulcer (dfu): wagner grade 1: partial- or full-thickness (superficial) * dfu: located on the anatomical foot; defined as distal to the medial malleolus * venous leg ulcer (vlu): partial or full thickness * vlu: located below the knee and above the ankle * presents with or without clinical signs of superficial infection * present for ≥4 weeks and \<52 weeks * wounds will be dry to moderately exudating * post-debridement wound area is ≥0.5 cm2 and ≤25 cm2 * if two or more ulcers are present, the index ulcer must additionally be: * the ulcer with the largest wound area * ≥3cm distance from any other ulcer on the affected limb * dfu: type 1 or type 2 diabetes (confirmed by the subject's medical history) * dfu: hgba1c \<9% at screening * gfr\>30 ml/min/1,73m2 * subject has adequate circulation to the affected extremity, as demonstrated by at least one of the following results within the past 30: * dorsum transcutaneous oxygen test (tcpo2): \>30mmhg; * subject's ankle-brachial index (abi) by doppler: ≥0.7 and ≤1.2; * doppler arterial waveforms, which are triphasic or biphasic at the ankle of the affected foot. for ankle-brachial pressure index (abpi): \>1.2, for toe brachial index (tbi): \>0.5 * a total lymphocyte count of more than 1500 cells/mm3 * albumin level of more than 3.5 g/dl * subject can ambulate at home or in the clinic with or without mobility aids * bmi ≤45 exclusion criteria: * subjects with wounds that have any of the following characteristics: • wounds that penetrate down to tendon, ligament, joint capsule or bone, underlying muscle tissue, or organs * tunnelling wounds * known or suspected local skin malignancy at the site of the ulcer * dfu: major structural abnormalities of the foot * dfu: active charcot deformity * vlu: inability to tolerate elastocompression (40 mm/hg) * wound duration \>1 year * subjects receiving any of the following prior therapies: * in the last 10 days: * chemical debridement * dakin's solution * medical honey therapy * in the last 30 days (or anticipated to require such medications during the study period): * cytotoxic chemotherapy * application of topical steroids to the ulcer surface * use of ≥14 days of immune suppressants (including systemic corticosteroids) or * subject is anticipated to require such medications during the study period * in the last 30 days: o study ulcer treatment with any advanced therapy, including, biomedical or topical growth factors, tissue engineered materials * in the last 6 months: * any amputation to the affected leg * revascularization (surgical or stenting) to the affected leg * known hypersensitivity to constituents of the product * osteomyelitis/bone infection of the affected foot/leg, as verified by x-ray within 30 days prior to screening * active cellulitis at the wound site * history of radiation at the ulcer site, regardless of duration * chronic kidney disease stage 4 or 5 * immune system disorders, including sle, aids or hiv * presence of any other pathology that would limit blood supply and compromise healing * revascularization procedure to increase blood flow in the target limb * presence of any condition (including current drug or alcohol abuse, medical or psychiatric condition) that is likely to impair understanding of, or compliance with the study * women of childbearing age (women aged \<55 years who have not undergone menopause) who are: * pregnant at time of enrolment * planning to become pregnant during the time of the study * have been pregnant within the last 6 months * breast-feeding * unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence) during the time of the study * concurrent enrolment in any other study